LA JOLLA, Calif., July 8, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced that Rachel Leheny, Ph.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025, at 2:0 ...

Core Insights - CalciMedica Inc. announced the publication of preclinical data and a post-hoc analysis of its lead candidate Auxora™ for treating acute kidney injury (AKI) with respiratory failure, highlighting its potential as a transformative treatment [1][3][5] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel therapies targeting calcium release-activated calcium (CRAC) channels for inflammatory and immunologic diseases [5][6] - The company’s lead product candidate, Auxora™, has shown positive clinical results in multiple trials and has been well-tolerated in over 350 critically ill patients [5] Clinical Trial Details - The KOURAGE trial is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Auxora in patients with severe AKI and respiratory failure, aiming to enroll approximately 150 patients [4] - The primary endpoint of the KOURAGE trial is the number of days alive without the need for a ventilator or dialysis, with secondary endpoints including all-cause mortality and decline in estimated glomerular filtration rate (eGFR) [4] Preclinical and Clinical Evidence - Preclinical models demonstrated that Auxora significantly increased glomerular filtration rate (GFR) and prevented mortality in AKI models [3] - A post-hoc analysis from the CARDEA trial indicated a 62.7% relative reduction and a 29.3% absolute reduction in mortality for patients treated with Auxora compared to placebo [3] Market Context - Approximately 3.7 million patients are hospitalized with AKI in the U.S. annually, with a high mortality risk of around 50% for those with severe AKI and respiratory failure [3]

Core Insights - CalciMedica Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies targeting calcium release-activated calcium (CRAC) channels for treating acute and chronic inflammatory and immunologic diseases [1][4] - The company will host a symposium titled "Auxora for the Treatment of AKI" at the 43rd Vicenza Course AKI-CRRT-EBPT and Critical Care Nephrology meeting from June 24-26 in Vicenza, Italy [1] Presentation Details - The symposium will feature several oral presentations, including an overview of CRAC channels by Dr. Sudarshan Hebbar, scheduled for June 24, 1:45-2:00 p.m. CEST [2] - Another presentation will discuss the role of IL-17 in the pathophysiology of acute kidney injury (AKI) by Dr. Javier Neyra, set for June 24, 2:00-2:20 p.m. CEST [2] - Dr. Lakhmir Chawla will present on the KOURAGE trial (NCT06374797) on June 24, 2:20-2:35 p.m. CEST [3] Company Overview - CalciMedica's proprietary technology aims to inhibit CRAC channels to modulate immune responses and protect against tissue cell injury, potentially addressing life-threatening inflammatory and immunologic diseases without approved therapies [4] - The lead product candidate, Auxora™, has shown positive clinical results in multiple trials and has been well-tolerated in over 350 critically ill patients [4] - The company is conducting several clinical trials, including a Phase 2b trial (CARPO – NCT04681066) for acute pancreatitis and a Phase 2 trial (CARDEA – NCT04345614) for COVID pneumonia, as well as the ongoing KOURAGE trial for AKI with associated acute hypoxemic respiratory failure [4]

Financial Performance - The company reported a net loss of $5.0 million for the three months ended March 31, 2025, with total operating expenses of $6.5 million and interest expense of $0.4 million[144]. - Net loss for the three months ended March 31, 2025, was $5.0 million, a significant increase of 3978% compared to a net income of $130,000 in the same period of 2024[158]. - Other income decreased by 75% to $1.5 million for the three months ended March 31, 2025, compared to $5.9 million in 2024[161]. - Cash used in operating activities for the three months ended March 31, 2025, was $4.9 million, primarily due to cash outlays for operations[179]. - Cash used in investing activities for the three months ended March 31, 2025, was $1.2 million, primarily from the purchase of short-term investments[181]. - The company has experienced significant operating losses since inception, except for the three-month period ending March 31, 2024[144]. Cash and Investments - As of March 31, 2025, the company had an accumulated deficit of $164.8 million and $24.6 million in cash, cash equivalents, and short-term investments[144]. - Cash, cash equivalents, and short-term investments totaled $24.6 million as of March 31, 2025[162]. - Cash provided by financing activities for the three months ended March 31, 2025, was $10.8 million, comprised of debt financing of $9.8 million and $1.0 million from the ATM[182]. - The Company expects cash requirements for its lease obligation to be approximately $95,000 over the next nine months[183]. Funding and Capital - The company raised gross proceeds of $20.4 million from a private placement transaction in January 2024, with net proceeds of approximately $19.0 million after deducting transaction costs[140]. - An underwritten public offering in November 2024 generated gross proceeds of $10.2 million from the sale of 2,720,000 shares at a price of $3.75 per share[141]. - A loan agreement was established for growth capital loans totaling up to $32.5 million, with $10 million funded on the closing date[143]. - The Company entered into a Loan Agreement for an initial $10.0 million of gross proceeds on February 28, 2025[163]. - The company filed a Shelf Registration Statement in August 2023 for the offering of up to $100.0 million in various securities[170]. Research and Development - The company expects research and development expenses to increase substantially as it continues to invest in clinical trials and regulatory approvals[149]. - Research and development expenses increased by 43% to $4.2 million for the three months ended March 31, 2025, compared to $2.9 million for the same period in 2024[158]. - Research and development expenses included a 271% increase in chemistry, manufacturing, and controls costs related to Phase 2 clinical trials of Auxora[159]. - The company is conducting a Phase 2 trial for Auxora in acute kidney injury with data expected around the end of 2025[136]. - The company has not generated any product revenue and does not expect to do so until successful development and regulatory approval of its product candidates[146]. - The company expects to need substantial additional capital to fund product candidates through regulatory approval and commercialization[164]. Operational Adjustments - The company has paused IND enabling preclinical work on several product candidates to focus resources on clinical programs, pending additional funding[137]. - General and administrative expenses decreased by 19% to $2.3 million for the three months ended March 31, 2025, down from $2.8 million in 2024[160].

Financial Performance - CalciMedica reported a net loss of $5.9 million for the first quarter of 2025, compared to a net income of $0.1 million for the same period in 2024[15]. - Total operating expenses for the first quarter of 2025 were $6.5 million, compared to $5.8 million for the same period in 2024[21]. - General and administrative expenses decreased to $2.3 million for the first quarter of 2025, down from $2.8 million in the same period of 2024[15]. Research and Development - Research and development expenses increased to $4.2 million for the three months ended March 31, 2025, up from $2.9 million in the same period of 2024, primarily due to activities related to the Phase 2 KOURAGE clinical trial[11][12]. - The Phase 2 KOURAGE trial is ongoing, with an expected enrollment of 150 patients and data anticipated around the end of 2025[4]. - CalciMedica plans to hold an end-of-Phase 2 meeting with the FDA around mid-2025 and aims to initiate a Phase 3 program in acute pancreatitis by the end of 2025[10]. - A post-hoc analysis from the Phase 2 CARDEA trial indicated a 62.7% relative reduction in mortality for patients treated with Auxora compared to placebo[5]. Financial Position - Cash, cash equivalents, and short-term investments totaled $24.6 million as of March 31, 2025, which is expected to fund operations into mid-2026[11]. - Total assets increased to $25.3 million as of March 31, 2025, compared to $19.8 million as of December 31, 2024[19]. - The company announced a credit facility providing up to $32.5 million, with an initial tranche of $10 million fully funded at close[8].

Company Overview - CalciMedica Inc. is a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses [3] - The company's lead product candidate, Auxora™, has shown positive and consistent clinical results in multiple completed efficacy clinical trials [3] Clinical Trials and Developments - CalciMedica has announced data for a Phase 2b trial (CARPO – NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS) [3] - The company completed a Phase 2 trial (CARDEA – NCT04345614) in patients with COVID pneumonia [3] - Currently, CalciMedica is conducting a Phase 2 trial (KOURAGE – NCT06374797) in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF), with data expected around the end of 2025 [3] - The company is also supporting an ongoing investigator-initiated Phase 1/2 trial (CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT), with an update expected in the second half of 2025 [3] Upcoming Events - Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica, will present at the Jones Healthcare and Technology Innovation Conference on April 9, 2025, at 11:00 a.m. PT [1] - A live webcast of the presentation will be available on CalciMedica's IR website, with a replay archived for 90 days [2]

Financial Condition - As of December 31, 2024, the company had an accumulated deficit of $159.8 million and reported a net loss of $13.7 million for the year [290]. - The company had $18.7 million in cash, cash equivalents, and short-term investments as of December 31, 2024, which is insufficient to fund product candidates through regulatory approval [293]. - The company expects to incur increasing levels of operating losses over the next several years, impacting stockholders' equity and working capital [290]. - The company has federal net operating loss (NOL) carryforwards of approximately $296.8 million, with $102.2 million generated prior to 2018 set to expire in 2026 unless utilized [442]. - The company has federal and state research and development credit carryforwards totaling $13.3 million and $3.1 million, respectively, with federal credits beginning to expire in 2027 [442]. Funding and Capital Requirements - The company will need to raise substantial additional funding to complete the development and commercialization of its product candidates [292]. - The company entered into a Loan and Security Agreement on February 28, 2025, for an initial growth capital loan of $10 million, with additional funding contingent on achieving certain clinical milestones [302]. - The company has primarily financed its operations through private placements and public offerings since its inception in October 2006 [292]. - The company anticipates that any acquisitions or strategic collaborations may increase capital requirements and could dilute stockholders [300]. - The company may need to increase expenditures for development and commercialization activities, which could require obtaining additional capital that may not be available on acceptable terms [424]. Clinical Development and Trials - The company has conducted several clinical trials for its lead product candidate, Auxora, including ongoing Phase 2 trials and plans for a Phase 3 trial [289]. - The company is highly dependent on the success of its lead product candidate, Auxora, which is currently in multiple clinical trials, including a Phase 1/2 trial and a Phase 2 trial initiated in July 2024 [311]. - Auxora recently completed a Phase 2b clinical trial, but the company has not yet advanced any product candidates into late-stage or pivotal trials [311]. - The company has not completed any late-stage or pivotal clinical trials or submitted a new drug application (NDA) to the FDA, which poses a risk to its ability to generate revenue [312]. - Clinical development is described as lengthy, expensive, and uncertain, with only a small percentage of programs entering clinical development receiving marketing approval [316]. Regulatory Challenges - The regulatory pathway for Auxora may be complex and time-consuming due to the novelty of the CRAC channel inhibition science and the lack of relevant experience with the indications being pursued [310]. - The FDA may grant accelerated approval for product candidates designed to treat serious conditions, contingent on the agreement to conduct additional post-approval studies [349]. - Regulatory approval processes are expensive and can take many years, with no guarantee of approval despite significant investment in clinical development [352]. - The FDA requires approval for any proposed product names, and failure to secure such approval may adversely affect the company's business [359]. - The company faces significant liability risks if found to have improperly promoted off-label uses of approved products [367]. Market and Competitive Landscape - The company faces substantial competition in the biotechnology and pharmaceutical industries, which may hinder its ability to develop and commercialize product candidates effectively [414]. - Competitors may obtain FDA or other regulatory approvals more rapidly, potentially establishing a strong market position before the company can enter the market [419]. - The company must prioritize specific treatment developments due to limited resources, which may lead to missed opportunities with potentially more commercially viable candidates [371]. - The competitive landscape includes larger companies with more resources and experience, as well as smaller firms and academic institutions, increasing the challenge for the company [418]. - The company is highly dependent on third-party payors for coverage and reimbursement, which are critical for product acceptance and profitability [390]. Intellectual Property and Compliance - The ability to obtain and maintain intellectual property protection is crucial for the commercialization of products, with uncertainties surrounding patent rights [459]. - The patent application process is complex and costly, with risks of failing to secure necessary protections for proprietary technologies [462]. - The company may face challenges in protecting its intellectual property rights globally due to prohibitively expensive patent filing and enforcement processes [478]. - The company may encounter claims challenging the inventorship or ownership of its patents, which could lead to litigation and potential loss of valuable intellectual property rights [482]. - The company may struggle to obtain necessary rights to product components and processes through acquisitions and in-licenses, impacting its development pipeline [483]. Operational Risks - The company relies on third parties for research and clinical trials, and any failure by these parties to meet obligations could delay development programs and increase costs [375]. - Manufacturing and supply of product candidates are dependent on third parties, with potential risks of limited supply or quality issues that could impair development efforts [384]. - The company has limited manufacturing arrangements, relying on a single source supplier in China for certain components, which increases risks related to geopolitical and regulatory changes [384]. - The company is increasingly dependent on information technology systems, which may be vulnerable to security breaches and disruptions, potentially affecting sensitive information and business operations [436]. - Cyber incidents have increased in frequency and sophistication, posing risks to the company's sensitive information and operational integrity [437]. Healthcare Regulations and Reimbursement - The company anticipates that obtaining reimbursement for its product candidates may be particularly difficult due to higher prices associated with branded therapeutics [396]. - The company expects pricing pressures due to trends in managed healthcare and legislative changes, which may hinder successful commercialization of new products [398]. - The European Union's reimbursement status for product candidates varies by member state, with ongoing efforts for transparency in pharmaceutical payments [452]. - Compliance with healthcare laws is critical, as violations could result in substantial penalties, including exclusion from government-funded programs [453]. - The Affordable Care Act has significantly impacted the U.S. pharmaceutical industry, with ongoing amendments and challenges that may affect the company's financial condition [446].

Financial Performance - CalciMedica reported a net loss of $13.7 million for the year ended December 31, 2024, a significant improvement from a net loss of $34.4 million in 2023[11]. - Total operating expenses decreased to $24,204 million in 2024 from $38,075 million in 2023, a reduction of approximately 36.4%[18]. - Net loss improved to $13,700 million in 2024 compared to a net loss of $34,357 million in 2023, representing a reduction of about 60.1%[18]. - Net loss per share decreased to $1.22 in 2024 from $7.66 in 2023, indicating a significant improvement in per-share performance[18]. - Overall, the financial performance indicates a positive trend with significant reductions in losses and operating expenses year-over-year[18]. Expenses - Research and development expenses decreased to $14.5 million in 2024 from $15.9 million in 2023, primarily due to a reduction in personnel expenses related to a merger[11]. - General and administrative expenses were $9.7 million in 2024, down from $22.2 million in 2023, reflecting a decrease in personnel expenses driven by one-time charges from the merger[11]. - Research and development expenses were $14,478 million in 2024, down from $15,859 million in 2023, reflecting a decrease of about 8.7%[18]. - General and administrative expenses significantly decreased to $9,726 million in 2024 from $22,216 million in 2023, a decline of approximately 56.3%[18]. - The company reported a loss from operations of $24,204 million in 2024, down from $38,075 million in 2023, a decrease of about 36.4%[18]. Assets and Funding - Cash, cash equivalents, and short-term investments totaled $18.7 million as of December 31, 2024, expected to fund operations into mid-2026[11]. - The total assets increased to $19.8 million as of December 31, 2024, compared to $12.2 million in 2023[16]. - The company secured a credit facility of up to $32.5 million to support its operations, with an initial tranche of $10 million already funded[10]. Clinical Trials and Development - Enrollment is ongoing in the Phase 2 KOURAGE trial, targeting 150 patients with severe acute kidney injury and associated respiratory failure, with data expected by the end of 2025[4]. - A post-hoc analysis from the Phase 2 CARDEA trial indicated a 62.7% relative reduction in mortality at day 30 for patients treated with Auxora compared to placebo[3]. - CalciMedica plans to hold an end-of-Phase 2 meeting with the FDA in mid-2025, aiming to initiate a Phase 3 program in acute pancreatitis by the end of 2025[8]. Leadership Changes - The company appointed Stephen Bardin as Chief Financial Officer in November 2024, enhancing its leadership team[9]. Other Income - Total other income rose to $10,504 million in 2024, up from $3,718 million in 2023, marking an increase of about 182.5%[18]. - Change in fair value of financial instruments increased to $9,490 million in 2024 from $3,168 million in 2023, a growth of approximately 199.2%[18]. Shareholder Information - Weighted-average number of shares outstanding increased to 11,245,915 in 2024 from 4,486,258 in 2023, reflecting an increase of approximately 150.1%[18].

Core Insights - CalciMedica is conducting a Phase 2 KOURAGE trial of Auxora™ for acute kidney injury (AKI) and expects data by the end of 2025 [1][4] - A post-hoc analysis from the Phase 2 CARDEA trial indicated a 62.7% relative reduction in mortality for patients treated with Auxora compared to placebo [1][4] - The company has sufficient cash to fund operations into mid-2026, with a cash position of $18.7 million as of December 31, 2024 [10] Clinical Updates - Enrollment in the KOURAGE trial is ongoing, targeting 150 patients with severe AKI and acute hypoxemic respiratory failure [4] - The CARDEA trial analysis included 38 patients with AKI and respiratory failure, showing a 29.3% absolute reduction in mortality at day 30 [4] - An end-of-Phase 2 meeting with the FDA is planned for mid-2025 to discuss a Phase 3 program for acute pancreatitis with systemic inflammatory response syndrome (SIRS) [4] Financial Performance - Research and development expenses decreased to $14.5 million in 2024 from $15.9 million in 2023, primarily due to reduced personnel expenses [10] - General and administrative expenses significantly decreased to $9.7 million in 2024 from $22.2 million in 2023, also due to reduced personnel costs [10] - The net loss for 2024 was $13.7 million, a reduction from a net loss of $34.4 million in 2023 [10][15] Corporate Developments - The company secured a credit facility of up to $32.5 million from Avenue Capital Group, providing financial support for ongoing operations [7] - Leadership was strengthened with the appointment of Stephen Bardin as Chief Financial Officer in November 2024 [9] - Alan Glicklich, M.D., was appointed to the Board of Directors in January 2025, bringing over 20 years of biotechnology experience [9]

Core Insights - CalciMedica Inc. has secured a credit facility of up to $32.5 million from Avenue Venture Opportunities Fund II, L.P. to support its product pipeline development [1][2] - The initial tranche of $10 million is fully funded at close, with additional tranches of up to $22.5 million contingent on achieving certain milestones [2] - The funding is expected to extend CalciMedica's cash runway into mid-2026, allowing the company to prepare for critical milestones in 2025, including data from its Phase 2 KOURAGE trial [3] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases [5] - The company's lead product candidate, Auxora™, has shown positive clinical results in multiple trials, including a Phase 2b trial for acute pancreatitis and ongoing trials for acute kidney injury and pediatric patients with asparaginase-induced pancreatic toxicity [5] - CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, California [5] Funding Details - The credit agreement has a term of 3.5 years and includes no minimum cash requirement or other financial covenants [2] - The funding will enable CalciMedica to maintain operations and support ongoing clinical trials, including anticipated discussions with the FDA regarding a Phase 3 program in acute pancreatitis [3][6] - Avenue Capital Group, managing approximately $12.1 billion in assets, aims to provide creative financing solutions to high-growth, venture capital-backed companies [4]